1. Field of the Invention
The present invention relates to means of determining the immune function of a human being or animal. In a number of diseases or other pathological conditions, the immune system response of the human or animal subject is depressed. As a result the subject becomes more susceptible to opportunistic infections, malignancies, or other pathological conditions against which a normal immune system would have protected the subject. Among the pathological conditions that depress the immune system are Acquired Immune Deficiency Syndrome (AIDS) and AIDS-related complex (ARC). Chemotherapy and aging are also associated with immune deficiency.
In other conditions or circumstances, immune system response may be excessive relative to what is medically desired. For example, lupus, multiple sclerosis, arthritis, and diabetes may involve excessive immune system response. When organ transplants are required, it is often medically desirable to lower the subject's immune system response to avoid rejection of the organ transplant.
Convenient, inexpensive, in vitro diagnostic tests for diagnosing impairment or level of immune function are presently unavailable. In particular, such quantitative tests are unavailable. However, such quantitative tests would be very useful in therapeutic regimes, for several purposes. Such tests would be helpful in assessing the remaining immune function of a person whose immune system has been damaged, such as by chemotherapy or AIDS, as a diagnostic indicating the need for or feasibility of other treatment and the appropriate extent thereof. Such tests are also helpful in titrating to an acceptable amount the dosage of substances known to impair immune function, in titrating the dosage of substances deliberately administered to modify (suppress or amplify) immune function, and qualitatively in determining whether a person or animal suffers from a condition impairing immune function.
2. Other Background
The inventor has discovered that lymphocyte dialysates contain immunodulators, which are materials or substances having therapeutic utility, as described in detail in U.S. Pat. No. 4,468,379. The '379 patent discloses a process for extracting such substances and methods of using them. Other processes are disclosed in pending U.S. application Ser. No. 643,724. In general, immunomodulators have the property of modulating the response of a subject's immune system to antigens to which the subject's system has been previously exposed. Amplifier immunomodulators, or amplifiers (or immunoamplifiers), amplify or accelerate immune response. Suppressor immunomodulators, or suppressors, suppress immune response.
Transfer factors have also been reported to have been derived from lymphocyte dialysates or leukocyte extracts. Immunomodulators have been distinguished from transfer factors, in that immunomodulators are not specific to particular antigens (whereas transfer factors are) and immunomodulators generically affect immune response to any antigen to which the subject has been exposed (whereas transfer factors do not). Transfer factors are reported to transfer an immune response only to antigens to which the donor was exposed, and to do so irrespective of whether the subject to which the factor is administered ever had previously been exposed to such antigens.
The inventor's '379 patent discloses procedures in which test subjects are exposed to antigens, with and without dosages of immunomodulators, and the immune responses are compared. The pending '724 application discloses similar information. The '724 application also discloses the treatment of AIDS and ARC patients with amplifiers to restore their immune function, in whole or in part, so long as enough residual immune function remains to permit the treatment to be effective. Abstracts published in April 1984 and April 1985, A. Arthur Gottlieb and J. L. Farmer, "Reconstitution of T cell function in AIDS patients by use of leukocyte-derived endogenous immunomodulators," Clinical Research 32: 504A and 33: 557, also describe the foregoing AIDS treatments in general terms; the abstracts also state that the authors observed that the patients demonstrated no or low responsiveness to PHA (phytohemagglutinin, a substance to which lymphocytes of healthy subjects respond) before therapy, while after therapy they displayed enhancement of their PHA responsiveness with associated increases in production of interleukin-2, and enhancement of delayed type hypersensitivity reaction to tetanus toxoid in several patients.
Other, as yet unpublished, work of the inventor, described in a co-pending application, "Tripeptides affecting immune response," Ser. No. 813,586 filed Dec. 26, 1985 (hereinafter referred to at times as the Tripeptides patent application), indicates that immunomodulatory effects similar to those obtained with the foregoing immunomodulators may be obtained by use of the tripeptide Tyr-Gly-Gly (TGG) and related molecules.